Tissue closure and tissue closing device

ABSTRACT

A living body tissue closing device includes an elongated body element, a clip (living body tissue closure) for closing a wound hole which penetrates a living body tissue membrane, and a thread. The body element includes a sheath, and elongated feeding and deformation arrangement. The elongated feeding and deformation arrangement includes a covered tube, a pusher tube, a thread anchoring cap, a guide wire, and a stopper. The clip includes a seal portion for covering the wound hole and a peripheral portion of the wound hole from one side of the living body tissue membrane, a deformation portion deformable between a first form in which the deformation portion can pass through the wound hole and a second form in which the deformation portion cooperates with the seal portion to sandwich the living body tissue membrane therebetween, and a fastener portion for retaining the deformation portion in the second form.

This application is a continuation of U.S. application Ser. No.11/474,488 filed on Jun. 26, 2006, which is a continuation-in-part ofinternational Application No. PCT/JP2004/019734 filed on Dec. 24, 2004and published in English and which claims priority to JapaneseApplication No. 2003-435843 filed on Dec. 26, 2003, the entire contentof all three of which is incorporated herein by reference.

TECHNICAL FIELD

This invention generally relates to a tissue closure and a tissueclosing device for living being. More specifically, this inventionpertains to a living body tissue closure and a living body tissueclosing device.

BACKGROUND DISCUSSION

Low-invasion operations carried out by inserting a device for diagnosisor treatment, such as a catheter, into a blood vessel or some othertissue are known and performed on a quite often basis. For example, totreat a constriction of the coronary artery of the heart, it isnecessary to insert a device such as a catheter into a blood vessel inorder to perform therapeutic treatment on the constriction.

This insertion of an instrument such as a catheter into a blood vesselis normally performed through a puncture formed by dissecting orpuncturing the femoral region. After the therapeutic treatment iscompleted, it is necessary to perform a staunching operation to stop thebleeding through the puncture. However, since the blood pressure uponbleeding (bleeding blood pressure) from the femoral artery is relativelyhigh, it is oftentimes necessary for a person involved in the medicalprocedure to use a finger of their hand to press down on the site for arelatively long period of time.

In recent years, to perform the stoppage of bleeding more readily andwith greater certainty, a suturing device has been developed which isadapted to be inserted through a wound hole to suture a hole formed in ablood vessel. For example, Japanese Translation of PCT for Patent No.Hei 8-504618 (corresponding to U.S. Pat. No. 5,304,184) discloses asuturing device configured such that a member which is expandable into ashape of a basket is provided at an end portion of the suturing device.Upon suturing, the member is inserted into a blood vessel and expandedinto the shape of a basket, and then a suture needle is inserted.Thereafter, the member expanded in the shape of the basket is closed tocatch the needle and then the end portion of the device is pulled off.

However, this suturing device can be somewhat problematic in that thereliability in catching the needle is relatively low. Further, after athread for suturing is threaded once through the needle, it is necessaryto replace the thread.

Therefore, the use of this suturing device requires additional lime andlabor for suturing.

Japanese Patent No. 2, 562,007 (corresponding to U.S. Pat. No.5,306,254) discloses a living body tissue closing device in which a hardseal portion and collagen sponge are connected to each other by athread.

The operational method associated with the use of this device involvesinserting the distal end of the body element of the device into a bloodvessel through a wound hole, and expanding a seal portion. Then, whilethe body element is pulled off slowly, the seal portion is placed intocontact with the wound hole and peripheral tissue of the wound hole. Ifthe body element is pulled off while the seal portion catches the woundhole, then the collagen sponge is expanded in the tissue on the woundhole from the distal end of the body element. Then, the body element ispulled off to the outside of the body and the thread which connects theseal portion and the collagen sponge is pulled to advance a knot anddraw the seal portion and the collagen sponge toward each other to stopthe bleeding. Finally, the thread is cut to complete the operation.

However, with this living body tissue closing device, the collagensponge is propelled toward the wound hole from the body element having adiameter substantially the same as that of the wound hole. Therefore,the living body tissue closing device has a problem in that the collagensponge is inserted into the blood vessel.

Further, with this living body tissue closing device, the collagensponge is sometimes expanded within the distal end of the body elementand does not come out of the body element.

Further, since the seal portion and the collagen sponge are connected toeach other by the thread, one of the seal portion and the collagensponge is capable of being displaced in any direction with respect tothe other. Therefore, the angle changes to an unexpected direction, andoperation of the living body tissue closing device is difficult.

Japanese Patent No. 3,133,059 (corresponding to U.S. Pat. No. 5,593,422)discloses a device in which a closing member with a thread attachedthereto is disposed in a blood vessel, a ring (locking member) is movedalong the thread, and the ring locks the thread outside the blood vesselto close up the opening formed in the wall of the blood vessel.

According to the device described, the closing member is secured to thewall of the blood vessel by fixing the ring to the thread.

However, in this just mentioned device, since the fixing operationinvolving securing the ring to the thread must be performed withinsubcutaneous tissues, the fixing operation can be difficult to perform.

Also, since the outside diameter of the ring needs to be dimensioned sothat the ring can be inserted into the opening, the ring mustnecessarily be relatively small in size, and there is the possibilitythat the ring may drop into the blood vessel through the opening formedin the wall of the blood vessel.

Further, since the closing member and the ring are connected to eachother by the thread, one of the closing member and the ring is capableof being displaced in any direction with respect to the other.Therefore, the angle between the two can change in an unexpecteddirection, and the living body tissue closing device is thus difficultto operate.

SUMMARY

According to one aspect, a tissue closure for closing an opening whichpenetrates a tissue membrane includes a seal portion having a flat faceportion for covering the opening and a surrounding portion of theopening from one side of the tissue membrane, a deformation portioncapable of expanding and contracting in two directions substantiallyperpendicular to each other, and a fastener portion positioned on theinner side of the deformation portion for retaining the deformationportion in a predetermined form, the deformation portion having anopening portion movable relative to the fastener portion and capable ofaccepting the fastener portion and a fixed portion integrated with thefastener portion and immovably with respect to the fastener portion.

With the tissue closure, a stanching operation for an opening formed ina tissue membrane such as a blood vessel wall can be performed readilywith a higher degree of accuracy and with a high degree of safety. Inother words, the opening can be closed readily and with certainty, andthe bleeding can be stanched completely.

In the tissue closure of the present invention, preferably the sealportion and the deformation portion are formed integrally from the samematerial.

In the tissue closure of the present invention, preferably thedeformation portion has a shape of a framework.

In the tissue closure of the present invention, preferably thedeformation portion has a quadrangular shape formed integrally from fourlinks and deforms such that two corner portions at diagonal positions ofthe quadrangular shape move toward and away from each other.

In the tissue closure of the present invention, preferably the fastenerportion is formed in such a manner as to control the distance betweenthe two corner portions.

In the tissue closure of the present invention, preferably the fastenerportion is formed in such a manner as to be capable of controlling thedistance between the two corner portions at a plurality of stages.

In the tissue closure of the present invention, preferably the fastenerportion is formed in such a manner as to be capable of controlling thedegree of deformation of the deformation portion at a plurality ofstages.

In the tissue closure of the present invention, preferably the fastenerportion is formed in such a manner as to allow deformation of thedeformation portion in a direction in which the degree of deformation ofthe deformation portion increases but block deformation of thedeformation portion in another direction in which the degree ofdeformation of the deformation portion decreases.

In the tissue closure of the present invention, preferably the fastenerportion has at least one pawl capable of being inserted into the openingportion and engaged with the deformation portion.

In the tissue closure of the present invention, preferably the sealportion has a shape of a plate.

In the tissue closure of the present invention, preferably thedeformation portion is connected for rocking motion to the seal portion.

In the tissue closure of the present invention, preferably the fastenerportion is formed integrally with the seal portion and the deformationportion from the same material.

In the tissue closure of the present invention, preferably the fastenerportion and the deformation portion are individually inclined withrespect to the seal portion.

In the tissue closure of the present invention, preferably the tissueclosure is made of a bioabsorbable material.

In the tissue closure of the present invention, preferably the tissueclosure has formed therein a hole through which a guide wire is to passthrough.

In the tissue closure of the present invention, preferably the fastenerportion has formed therein a hole through which a string for pulling thetissue closure is to be threaded.

In the tissue closure of the present invention, preferably the tissuemembrane is a blood vessel wall, and the one side is an inner surface ofthe blood vessel wall.

According to another aspect of the present invention, there is provideda tissue closure for closing an opening which penetrates a tissuemembrane, including, a seal portion having a shape of a plate forcovering the opening and a surrounding portion of the opening from oneside of the tissue membrane, a deformation portion having a shape of aframework deformable between a contracted form in which the deformationportion extends in a direction substantially perpendicular to the sealportion and is contracted in a direction substantially parallel to theseal portion and an expanded form in which the deformation portion iscontracted in the direction substantially perpendicular to the sealportion and is expanded in the direction substantially parallel to theseal portion, and a fastener portion for retaining the deformationportion when the deformation portion is deformed to a predetermined formbetween the contracted form and the expanded form.

With the tissue closure, a stanching operation for an opening formed ina tissue membrane can be performed readily with a higher degree ofaccuracy and with a high degree of safety. In other words, the openingcan be closed readily and with certainty, and the bleeding can bestanched completely.

In the tissue closure of the present invention, preferably thedeformation portion has a shape like a pantograph.

In the tissue closure of the present invention, preferably thedeformation portion has a polygonal annular shape formed by bending abelt-like member by a plural number of times.

In the tissue closure of the present invention, preferably thedeformation portion has a quadrangular shape formed integrally from fourlinks and deforms such that two corner portions at diagonal positions ofthe quadrangular shape move toward and away from each other.

Preferably, the tissue closure of the present invention further includesa connecting portion for connecting the seal portion and the deformationportion to each other.

In the tissue closure of the present invention, preferably thedeformation portion has a projection provided on the outer side thereofon the seal portion side and projecting toward the seal portion side.

With the tissue closure, the projection is positioned in the proximityof the opening closed with the tissue closure, and the opening istightened strongly by the projection. Consequently, the bleeding can bestanched with a higher degree of certainty.

Further, even if failure in stanching (for example, when the bloodvessel wall or the subcutaneous tissue is so hard that the deformationportion cannot be expanded or the like) occurs and manual compressionbecomes required and force in the direction in which the tissue closureis inserted transcutaneously into the blood vessel is applied to thetissue closure by the manual compression, a drop (omission) of thetissue closure into the blood vessel can be prevented by the projection.This enhances the safety.

According to a further aspect of the present invention, there isprovided a tissue closure having a seal portion for covering an openingwhich penetrates a tissue membrane and a surrounding portion of theopening from one side of the tissue membrane, the tissue closure beingadapted to close the opening, the tissue closure comprising: at least ata portion having a framework body deformable between a contracted formin which the portion is extended in a direction substantiallyperpendicular to a reference plane and is contracted in a directionsubstantially parallel to the reference plane and an expanded form inwhich the portion is contracted in the direction substantiallyperpendicular to the reference plane and is expanded in the directionsubstantially parallel to the reference plane.

With the tissue closure, a stanching operation for an opening formed ina tissue membrane such as a blood vessel wall can be performed readilywith a higher degree of accuracy and with a high degree of safety. Inother words, the opening can be closed readily and with certainty, andthe bleeding can be stanched completely.

In the tissue closure of the present invention, preferably the tissueclosure has a fastener portion for retaining the portion when theframework body is placed into a predetermined form between thecontracted form and the expanded form. According to a still furtheraspect of the present invention, there is provided a tissue closure forclosing an opening which penetrates a tissue membrane of a livingorganism lumen, including, a seal portion for being inserted into theliving organism lumen to cover the opening and a surrounding portion ofthe opening from an inner surface of the tissue membrane, the sealportion being formed such that the longest portion thereof has a lengthset smaller than the inner diameter of the living organism lumen intowhich the seal portion is inserted.

With the tissue closure, a stanching operation for an opening formed ina tissue membrane such as a blood vessel wall can be performed readilywith a higher degree of accuracy and with a high degree of safety. Inother words, the opening can be closed (closed up) readily and withcertainty, and the bleeding can be stanched completely.

Preferably, the tissue closure of the present invention further includesa deformation portion deformable between a first form in which thedeformation portion can pass through the opening and a second form inwhich the deformation portion can cooperate with the seal portion tosandwich the tissue membrane therebetween from the other side of thetissue membrane.

Preferably, the tissue closure of the present invention further includesa fastener portion for retaining the deformation portion in the secondform.

In the tissue closure of the present invention, preferably the sealportion is connected for turning motion around an axis of turning motionto the deformation portion.

In the tissue closure of the present invention, preferably the sealportion has a shape of a plate, and the length of the longest portion ofthe seal portion is 6 mm or less.

According to a yet further aspect of the present invention, there isprovided a tissue closure for closing an opening which penetrates atissue membrane, including, a seal portion for covering the opening anda surrounding portion of the opening from one side of the tissuemembrane, and a retaining portion for cooperating with the seal portionto sandwich the tissue membrane therebetween from the other side of thetissue membrane and retain the seal portion on the one side, theretaining portion having the seal portion connected thereto for turningmotion around an axis of turning motion.

With the tissue closure, a stanching operation for an opening formed ina tissue membrane such as a blood vessel wall can be performed readilywith a higher degree of accuracy and with a high degree of safety. Inother words, the opening can be closed readily and with certainty, andthe bleeding can be stanched completely.

In the tissue closure of the present invention, preferably a connectingportion between the seal portion and the retaining portion hasflexibility such that, as the connecting portion is bent, the sealportion is turned.

In the tissue closure of the present invention, preferably the sealportion has a shape of a plate, and the retaining portion has a shape ofa framework deformable between a first form in which the retainingportion can pass through the opening and a second form in which theretaining portion can cooperate with the seal portion to sandwich thetissue membrane therebetween from the other side of the tissue membrane.

According to a yet further aspect of the present invention, there isprovided a tissue closing device, including, any tissue closure of thepresent invention, and an elongated arrangement device for removablyretaining, at a distal end portion thereof, the tissue closure, thetissue closure being adapted to be arranged into a living organism andclose an opening which penetrates a tissue membrane.

With the tissue closing device, a stanching operation for an openingformed in a tissue membrane such as a blood vessel wall can be performedreadily with a higher degree of accuracy and with a high degree ofsafety.

In other words, the opening can be closed (closed up) readily and withcertainty, and the bleeding can be stanched completely.

Preferably, the tissue closing device of the present invention furtherincludes displacement means for displacing the seal portion so that theseal portion may extend substantially in parallel to an axial directionof the arrangement device.

In the tissue closing device of the present invention, preferably thedisplacement means has a contacting portion provided at the distal endportion of the arrangement device for contacting with a face of the sealportion on the deformation portion side.

In the tissue closing device of the present invention, preferably thetissue closure includes a deformable deformation portion adjacent theseal portion, and the tissue closing device further includes a retainerfor retaining the deformation portion of the tissue closure at thedistal end portion of the arrangement device.

In the tissue closing device of the present invention, preferably theretainer includes a deformation portion pulling means for pulling thedeformation portion to a proximal end side of the arrangement device.

According to a yet further aspect of the present invention, there isprovided a tissue closing device for closing an opening which penetratesa tissue membrane, including, . . . an elongated body element having adistal end portion capable of passing though the opening, a tissueclosure removably mounted at the distal end portion of the body elementand capable of passing through the opening together with the distal endportion of the body element to close the opening, and a deformationmeans, the tissue closure including, a seal portion for covering theopening and a surrounding portion of the opening from one side of thetissue membrane, a deformation portion having a shape of a frameworkdeformable to a first form in which the deformation portion can passthrough the opening and deformable by the deformation means to a secondform in which the deformation portion cooperates with the seal portionto sandwich the tissue membrane therebetween from the opposite side ofthe tissue membrane, and a fastener portion for retaining thedeformation portion in the second form.

With the tissue closing device, a stanching operation for an openingformed in a tissue membrane such as a blood vessel wall can be performedreadily with a higher degree of accuracy and with a high degree ofsafety.

In other words, the opening can be closed (closed up) readily and withcertainty, and the bleeding can be stanched completely.

According to a yet further aspect of the present invention, there isprovided a tissue closing device for closing an opening which penetratesa tissue membrane, including, an elongated body element having a distalend portion capable of passing though the opening, a tissue closureremovably mounted at the distal end portion of the body element andcapable of passing through the opening together with the distal endportion of the body element to close the opening, and deformation means,the tissue closure including, a seal portion for covering the openingand a surrounding portion of the opening from one side of the tissuemembrane, a deformation portion deformable to a first form in which thedeformation portion can pass through the opening and deformable by thedeformation means to a second form in which the deformation portioncooperates with the seal portion to sandwich the tissue membranetherebetween from the opposite side of the tissue membrane, and afastener portion for retaining the deformation portion in the secondform, the seal portion and the deformation portion being formedintegrally from the same material.

With the tissue closing device, a stanching operation for an openingformed in a tissue membrane such as a blood vessel wall can be performedreadily with a higher degree of accuracy and with a high degree ofsafety.

In other words, the opening can be closed readily and with certainty,and the bleeding can be stanched completely.

In the tissue closing device of the present invention, preferably thedeformation portion has a shape of a framework.

In the tissue closing device of the present invention, preferably thedeformation portion has an opening portion into which at least part ofthe fastener portion can be inserted.

In the tissue closing device of the present invention, preferably thefastener portion has at least one pawl capable of being inserted intothe opening portion and engaged with the deformation portion.

In the tissue closing device of the present invention, preferably thedeformation portion has a quadrangular shape formed integrally from fourlinks and deforms such that two corner portions at diagonal positions ofthe quadrangular shape move toward and away from each other.

In the tissue closing device of the present invention, preferably thefastener portion is formed in such a manner as to control the distancebetween the two corner portions.

In the tissue closing device of the present invention, preferably thefastener portion is formed in such a manner as to be capable ofcontrolling the distance between the two corner portions at a pluralityof stages.

In the tissue closing device of the present invention, preferably thefastener portion is formed in such a manner as to be capable ofcontrolling the degree of deformation of the deformation portion at aplurality of stages.

In the tissue closing device of the present invention, preferably thefastener portion is formed in such a manner as to allow deformation ofthe deformation portion in a direction in which the degree ofdeformation of the deformation portion increases but block deformationof the deformation portion in another direction in which the degree ofdeformation of the deformation portion decreases when the deformationportion is in the second form.

In the tissue closing device of the present invention, preferably theseal portion has a shape of a plate.

In the tissue closing device of the present invention, preferably thedeformation portion is connected for rocking motion to the seal portion.

In the tissue closing device of the present invention, preferably thefastener portion is formed integrally with the seal portion and thedeformation portion from the same material.

In the tissue closing device of the present invention, preferably thefastener portion and the deformation portion are individually inclinedwith respect to the seal portion.

In the tissue closing device of the present invention, preferably thetissue closure is made of a bioabsorbable material.

In the tissue closing device of the present invention, preferably thetissue closure has formed therein a hole through which a guide wire isto pass through.

Preferably, the tissue closing device of the present invention furtherincludes pulling means for pulling the tissue closure, the deformationportion being deformed by the deformation means while the tissue closureis being pulled by the pulling means.

In the tissue closing device of the present invention, preferably thepulling means is a string.

In the tissue closing device of the present invention, preferably thefastener portion has a hole through which the string is to be threaded.

In the tissue closing device of the present invention, preferably thedeformation means presses the deformation portion to deform thedeformation portion into the second form.

In the tissue closing device of the present invention, preferably thedeformation means is, at least at a portion thereof, a tubular memberprovided on the body element.

In the tissue closing device of the present invention, preferably thetissue membrane is a blood vessel wall, and the one side is an innersurface of the blood vessel wall while the opposite side is an outersurface of the blood vessel wall.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a perspective view of a first embodiment of a tissue closingdevice as disclosed herein.

FIGS. 2( a)-(c) are an elevational view, a perspective view and apartial plan view respectively of the tissue closure forming a part ofthe tissue closing device shown in FIG. 1.

FIG. 3 is a side elevational view showing different examples of aconfiguration of the tissue closure of the tissue closing device shownin FIG. 1.

FIGS. 4( a) and 4(b) are a side elevational view and a perspective viewrespectively of further examples of a configuration of the tissueclosure of the tissue closing device shown in FIG. 1.

FIG. 5 is a side elevational view showing a still further example of aconfiguration of the tissue closure of the tissue closing device shownin FIG. 1.

FIG. 6 is a cross-sectional view illustrating on operational aspect ofthe tissue closing device shown in FIG. 1.

FIG. 7 is a cross-sectional view illustrating another operational aspectof the tissue closing device shown in FIG. 1.

FIG. 8 is a sectional view illustrating another operational aspect ofthe tissue closing device shown in FIG. 1.

FIG. 9 is a sectional view illustrating a further operational aspect ofthe tissue closing device shown in FIG. 1.

FIG. 10 is a sectional view illustrating a further operational aspect ofthe tissue closing device shown in FIG. 1.

FIG. 11 is a sectional view illustrating yet another operational aspectof the tissue closing device shown in FIG. 1.

FIG. 12 is a sectional view illustrating another operational aspect ofthe tissue closing device shown in FIG. 1.

FIG. 13 is a perspective view of a second embodiment of a tissue closingdevice disclosed herein.

FIGS. 14( a)-(d) are perspective views of different operational aspectsof the tissue closure of the tissue closing device shown in FIG. 13.

FIG. 15 is a perspective view of another example of a configuration ofthe tissue closure of the tissue closing device shown in FIG. 13.

FIG. 16 is a sectional view illustrating an operational aspect of thetissue closing device shown in FIG. 13.

FIG. 17 is a sectional view illustrating another operational aspect ofthe tissue closing device shown in FIG. 13.

FIG. 18 is a perspective view of a third embodiment of a tissue closingdevice described herein.

FIGS. 19( a)-(c) are perspective views illustrating various operationalaspects of the tissue closing device shown in FIG. 18.

FIGS. 20( a)-(e) are perspective views illustrating other operationalaspects of the tissue closing device shown in FIG. 18.

FIG. 21 is a schematic illustration for explanatory purposes showingtissue closing device positioned in an artery.

DETAILED DESCRIPTION

A first embodiment of the living body tissue closing device disclosedherein will be described below with reference to FIGS. 1-12. Forpurposes of convenience in description, in FIGS. 1 and 6-11, the leftlower side is referred to as the “distal end” and the right upper sideis referred to as the “proximal end”. Further, in FIGS. 2-5 and 12,although the upper side of the living body tissue closing device as awhole in these figures is the “proximal end” and the lower side is the“distal end”, as regards the clip (living body tissue closure) 4, theupper side in the drawing figures is referred to as the “distal end” andthe lower side is referred to as the “proximal end”.

The living body tissue closing device 1 is a device for closing atransdermally penetrating wound hole (opening which penetrates a livingbody tissue membrane) which is formed, for example, in a living organismlumen such as a blood vessel, an internal organ of a living organism ora living body tissue membrane such as an internal tissue of a livingorganism.

As shown in FIGS. 7 and 8, the living body tissue closing device 1includes an elongated body element 2, and a clip 4 movably located atthe distal end portion of the body element 2 and serving as a livingbody tissue closure (closing up section) for closing a wound holepenetrating a living body tissue membrane. The living body tissueclosing device 1 further includes a thread (thread-like member or stringmember) 8 serving as pulling means for pulling the clip 4.

As shown in FIGS. 1, 6 and 7, the body element 2 includes a sheath 5having a through-hole 51 extending through a central portion thereof inthe axial direction, and an elongated feeding and deformation means(delivery device) 3 removably mounted on the sheath 5. During astaunching operation (operation of closing a wound hole), the distal endportions of the sheath 5, the feeding and deformation means 3 and theclip 4 individually penetrate the wound hole. In other words, they areinserted into a lumen (living organism lumen) of a living organism suchas a blood vessel through the wound hole.

The sheath 5 has a substantially cylindrical shape and has a hub 52 atthe proximal end portion thereof. A circumferentially expending groove53 is provided on the outer periphery of the hub 52 near the proximalend.

For the sheath 5, a sheath (introducer sheath) dwelling after treatment(PCI) is performed using a catheter or after treatment of a diagnosis(CAG) may be used. Alternatively, a sheath for exclusive use with theliving body tissue closing device 1 may be used.

The description above describes the sheath 5 as a component of the bodyelement 2. However, the sheath 5 need not be included in components ofthe body element 2.

The feeding and deformation means 3 includes a covered tube (tubularmember) 6, a pusher tube (tubular member) 7, a thread anchoring cap(thread retaining member) 9, a guide wire 11 having one end secured tothe thread anchoring cap 9, and a stopper 12. The covered tube 6 and thepusher tube 7 constitute parts that assist in feeding the clip 4 andpressing a deformation portion 42 of the clip 4 (described in moredetail below) to deform the deformation portion 42 into a second form.

The covered tube 6 includes a tube body 61 and a hub 62 provided at theproximal end portion of the tube body 61. The hub 62 has a cylindricaltubular portion 621. The clip 4 is removably located (retained) at thedistal end portion of the covered tube 6. In this instance, the clip 4is mounted such that the deformation portion 42 of the clip is retainedin a lumen at the distal end portion of the covered tube 6.

An inwardly directed circumferentially extending rib 622 is formed on aninner circumferential face of the tubular portion 621. This rib 622 isadapted to engage the groove 53 formed on the hub 52 of the sheath 5.Further, a circumferentially extending groove 623 is formed on the outercircumferential face of the hub 62.

The inner diameter of the tubular portion 621 of the huh 62 is a littlegreater than the outer diameter of the hub 52 of the sheath 5, and theouter diameter of the tube body 61 is a little smaller than the innerdiameter of the sheath 5. Consequently, the tube body 61 of the coveredtube 6 can be inserted into the sheath 5 while the hub 52 of the sheath5 can be inserted into the tubular portion 621 of the hub 62 of thecovered tube 6, with the rib 622 of the hub 62 engaging the groove 53 ofthe hub 52. Where the rib 622 is engaged with the groove 53, one of thesheath 5 and the covered tube 6 is blocked from coming off the other,and this facilitates operation.

The pusher tube 7 includes a tube body 71 and a hub 72 provided at theproximal end portion of the tube body 71. The hub 72 has a cylindricaltubular portion 721. The pusher tube 7 is adapted to push out the clip4, disposed at the distal end portion of the covered tube 6, from thecovered tube 6 so as to be released from the covered tube 6.

A circumferentially extending rib 722 is formed on the innercircumferential face of the tubular portion 721. This rib 722 is adaptedto engage the groove 623 formed on the tube body 61 of the covered tube6.

The outer diameter of the distal end portion of the hub 72 is smallerthan the outer diameter of the tubular portion 721. A circumferentiallyextending rib (flange) 723 is formed on the outer circumferential faceof the hub 72 at the proximal end of the hub 72.

The inner diameter of the tubular portion 721 of the hub 72 is a littlegreater than the outer diameter of the hub 62 of the covered tube 6, andthe outer diameter of the tube body 71 is a little smaller than theinner diameter of the covered tube 6. Consequently, the tube body 71 ofthe pusher tube 7 can be inserted into the covered tube 6 while the hub62 of the covered tube 6 can be inserted into the tubular portion 721 ofthe hub 72 of the pusher tube 7, with the rib 722 of the hub 72 engagingthe groove 623 of the hub 62. With the rib 722 engaged with the groove623, the possibility that one of the covered tube 6 and the pusher tube7 will separate (come out from) from the other is blocked, and thisfacilitates operation.

The thread anchoring cap 9 is removably mounted on the hub 72 of thepusher tube 7 and possesses a cylindrical tubular portion 91. Acircumferentially extending groove 92 adapted to engage the rib 723formed on the hub 72 of the pusher tube 7 is formed on the innercircumferential face of the tubular portion 91.

One end of the guide wire 11 is secured in the tubular portion 91 of thethread anchoring cap 9.

When the thread 8 is disposed between the thread anchoring cap 9 and thehub 72 of the pusher tube 7, and the thread anchoring cap 9 is mountedon the hub 72 until the rib 723 is engaged with the groove 92, thepossibility that the thread anchoring cap 9 will come out from or beseparated from the hub 72 of the pusher tube 7 is inhibited orprevented, and the thread 8 is sandwiched between and retained by thetubular portion 91 of the thread anchoring cap 9 and the rib 723 of thehub 72.

The stopper 12 is removably mounted on the tube body 71 of the pushertube 7. The stopper 12 includes a substantially C-shaped attachingportion 121 and a gripping portion 122. The stopper 12 is mounted on thetube body 71 in the proximity of the hub 72 by fitting the tube body 71of the pusher tube 7 into the attaching portion 121. The stopper 12 ismounted on the tube body 71 at a position generally indicated by thebroken line in FIG. 1.

As shown in FIGS. 1 and 2, the clip (living body tissue closure) 4includes a seal portion 41, a deformation portion or sustaining portion42 deformable between a first form and a second form, and a fastener orretaining portion 43 for retaining the deformation portion 42 in thesecond form. Preferably, the seal portion 41, the deformation portion 42and the fastener portion 43 are formed integrally in one piece from thesame material.

The seal portion 41 is a member having a fiat face portion (flat face)for covering a wound hole and a surrounding portion of the wound hole(the portion of a living body tissue membrane including the wound hole)from one side (inner surface) of the living body tissue membrane. In theillustrated embodiment, the seal portion 41 is plate-shaped so that itpossesses a substantially rectangular shape as viewed in plan.

The deformation portion 42 is frame-shaped and is adapted to be deformedfrom a basic or initial form (shape) to a first form in which it canpass through a wound hole and to a second form in which it cooperateswith the seal portion 41 to sandwich the living body tissue membranetherebetween to sustain the seal portion on one side of the living bodytissue membrane. The deformation portion 42 thus cooperates with theseal portion 41 so that the living body tissue membrane is sandwiched orpositioned between the seal portion 42 and the deformation portion 42,with the seal portion 41 positioned on one side (the inner surface side)of the living body tissue membrane and the deformation portion 42positioned on the other side (outer surface side) of the living bodytissue membrane to retain or hold the seal portion 41 to the one side ofthe living body tissue membrane. Accordingly, the deformation portion 42forms a retainer which cooperates with the seal portion 41 positioned onone side of the living body tissue membrane to sandwich the living bodytissue membrane therebetween from the other side of the living bodytissue membrane to retain the seal portion to the one side. Where theliving body tissue membrane is a blood vessel wall (living organismlumen wall), the one side at which the seal portion 41 is positioned isthe inner surface of the blood vessel wall (living organism lumen wall)while the other side at which the deformation portion 42 is positionedis the outer surface of the blood vessel wall (living organism lumenwall).

Here, in the present embodiment, the deformation portion 42 has aquadrangular shape (quadrangular framework) like a pantograph formedfrom four links connected integrally to each other. With respect to thetwo diagonally oppositely located corner portions 421, 422 at the upperand lower positions in FIG. 2, the lower side corner portion 422 (on theseal portion 41 side) in FIG. 2 is connected to the seal portion 41 andserves as a fixed portion which cannot move relative to the seal portion41 or the fastener portion 43. Consequently, when the deformationportion 42 is deformed, the diagonally opposite corner portions 421, 422move toward and away from each other.

Accordingly, the deformation portion 42 can be deformed to expand orcontract in two directions perpendicular to each other, and can alsorock (pivot) with respect to the seal portion 41 (turn around one axisof turning motion) as the four corner portions (corner) bend likearticulations. In other words, the seal portion 41 can rock (turn aroundone axis of turning motion) with respect to the deformation portion 42.In this instance, the connecting portion between the seal portion 41 andthe corner portion 422 of the deformation portion 42 is flexible, and asthe connecting portion bends (is elastically deformed), the seal portion41 turns.

Further, the upper face (surface on the opposite side to the sealportion 41) of the corner portion 421 on the upper side in FIG. 2 (onthe opposite side to the seal portion 41) exhibits a substantially flatface or surface.

A substantially H-shaped slit 424 is formed in the corner portion 421 asshown in FIG. 2( c). The slit 424 forms an opening extending through theframework-shaped deformation portion 42. At least part of the fastenerportion 43 can be inserted, fitted or received in the corner portion 421by way of the slit 424.

The fastener portion 43 possesses a bar-like shape. The fastener portion43 is positioned within the interior of the framework defined by theplural sides of the deformation portion 42 and is connected at itsproximal end portion (lower side end portion in FIG. 2( a)) to the innersurface of the corner portion 422 so that the fastener portion 43 isconnected to the seal portion 41 via the corner portion 422.

Consequently, the fastener portion 43 can rock (turn or pivot about asingle axis of honing/pivoting motion) together with the deformationportion 42 with respect to the seal portion 41. In other words, the sealportion 41 is able to pivot or turn with respect to the deformationportion 42 and the fastener portion 43 about a single axis (i.e., therelative pivoting/turning movement between the seal portion 41 on theone hand and the deformation portion 42 and fastener portion 43 on theother hand is limited to pivoting/turning movement in a single plane).

A number of pawls 431 (four in the illustrated example) are formed onopposite sides or surfaces of the fastener portion 43 in the leftwardand rightward direction relative to the illustration in FIG. 2( a). Thepawls 431 are juxtaposed in a spaced relationship by a predetermineddistance from each other in the longitudinal direction of the fastenerportion 43 (upward and downward direction in FIG. 2 a)).

If the above-described feeding and deformation means 3 (body element 2)is moved in a direction toward the distal end thereof, the distal endportions of the covered tube 6 and the pusher tube 7 are brought intocontact with the upper face 423 of the corner portion 421 of thedeformation portion 42 or with a part of the deformation portion 42around the upper face 423 at the upper side in FIG. 2( a). Thus, thecorner portion 421 of the deformation portion 42 is pressed toward thelower side in FIG. 2( a) (i.e., toward the corner portion 422) by thecovered tube 6 and the pusher tube 7. At this time, the fastener portion43 is positioned within the pusher tube 7 and does not present anobstacle (such as shown in FIG. 10).

As the corner portion 421 of the deformation portion 42 moves to thelower side in FIG. 2( a), the upper side end portion of the fastenerportion 43 in FIG. 2( a) and the uppermost ones of the pawls 431 of thefastener portion 43 in FIG. 2( a) pass through the slit 424 formed inthe corner portion 421 and are brought into engagement with the cornerportion 421 as generally illustrated in FIG. 10.

If the pushing force applied by the covered tube 6 and the pusher tube 7is canceled in this state, the shape of the deformation portion 42 ismaintained by the engagement between the pawls 431 and the cornerportion 421. Further, even if the corner portion 421 of the deformationportion 42 is pushed in the upper direction in FIG. 2( a), the shape ofthe deformation portion 42 is maintained.

It is to be noted that, as described in more detail below, the operationdescribed above is performed while the fastener portion 43 of the clip 4is being pulled by the thread 8.

If the feeding and deformation means 3 (body element 2) is further movedin the direction toward the distal end thereof, the corner portion 421of the deformation portion 42 is further pressed to the lower side inthe downward direction in FIG. 2( a) by the covered tube 6 and thepusher tube 7. Consequently, the corner portion 421 of the deformationportion 42 further moves to the lower side in the downward direction inFIG. 2( a) while the pawls 431 of the fastener portion 43 successivelypass through the slit 424 in the corner portion 421, until the lowermostones of the pawls 431 in FIG. 2( a) are fully engaged with the cornerportion 421 as generally shown in FIGS. 11 and 12.

As mentioned above, even if the pushing force applied by the coveredtube 6 and the pusher tube 7 is cancelled in this state, and even if thecorner portion 421 of the deformation portion 42 is pushed to the upperside in the upward direction in FIG. 2( a), the shape of the deformationportion 42 is maintained. This similarly applies also to an intermediatestage of deformation.

In this manner, the deformation portion 42 is deformed such that thecorner portion 421 and the corner portion 422 approach each other, orare positioned closer to one another compared to the basic state, toestablish the second form of the clip 4 in which the deformation portion42 cooperates with the seal portion 41 to sandwich a living body tissuemembrane therebetween to close a wound hole, with the pawls 431 engagedwith the corner portion 421 to maintain this second form.

In the second form of the deformation portion 42, deformation of thedeformation portion 42 in a direction in which the degree of deformationof the deformation portion 42 decreases is inhibited or blocked by thefastener portion 43, while deformation in the other direction in whichthe degree of deformation of the deformation portion 42 increases ispermitted. Thus, the degree of deformation of the deformation portion 42can be controlled or adjusted to a plurality of stages. In particular,in the second form of the deformation portion 42, deformation of thedeformation portion 42 in the direction in which the corner portion 421and the corner portion 422 are moved away from each other is inhibitedor blocked by the fastener portion 43, whereas deformation of thedeformation portion 42 in the other direction in which the cornerportion 421 and the corner portion 422 move toward each other ispermitted, and the distance between the two corner portions 421, 422 canbe controlled or adjusted to a plurality of stages. Consequently, theliving body tissue closing device 1 has useful application in a varietyof different conditions and under a variety of different circumstancessuch. For example, the device can be sued with a person who has a thickliving body tissue membrane, a person who has a thin living body tissuemembrane, a person who has a hard living body tissue membrane, and aperson who has a soft living body tissue membrane.

A hole (through-hole) 432 through which the thread 8 is to be threadedis formed at the distal end portion of the fastener portion 43. As shownin FIGS. 1 and 6, the thread 8 passes through the slit 424 of the cornerportion 421 of the deformation portion 42 from the upper side in FIG. 1,through the hole 432 of the fastener portion 43 and further through theslit 424 from the lower side in FIG. 1.

In this state, the opposite end portions of the thread 8 are threadedthrough the inside of the pusher tube 7 and pulled out to the outsidefrom the proximal end portion of the pusher tube 7. In this state, thethread anchoring cap 9 is then mounted on the hub 72, whereupon theopposite end portions of the thread 8 are sandwiched (retained) betweenthe thread anchoring cap 9 and the hub 72, whereby the opposite endportions of the thread 8 can be retained at the proximal end portion ofthe pusher tube 7. In other words, the thread 8 has the fastener portion43 retained at an end portion thereof, and in this state the thread 8 isretained at the other end portion thereof to the proximal end portion ofthe pusher tube 7.

As shown in FIGS. 1 and 2, a hole (through-hole) 425 through which theguide wire 11 is to be passed is formed in the deformation portion 42 inthe proximity of the corner portion 422. Further, a hole (through-hole)411 through which the guide wire 11 is to be passed is formed in theseal portion 41. The hole 411 opens at one end to the left side endportion of the seal portion 41 in FIG. 2( b) and opens at the other endat the upper surface of the seal portion 41 in FIG. 2( b) in proximityto the hole 425.

As shown in FIG. 6, the guide wire 11 passes through the slit 424 at thecorner portion 421 of the deformation portion 42, passes through thehole 425 in the deformation portion 42 and passes through the hole 411in the seal portion 41.

At least a part of the clip 4 is preferably formed from a bioabsorbablematerial. Preferably, the entire clip 4 is formed from a bioabsorbablematerial. In this instance, since the clip 4 is absorbed by a livingorganism after a predetermined interval of time and does not finallyremain in the living organism, an influence on the human body can beeliminated.

Examples of bioabsorbable material to be used for the clip 4 include asimple substance of polylactic acid, polyglycolic acid, or polydioxanonor a complex of them.

It is to be noted that, as a component material of the clip 4, not onlya bioabsorbable material but also a biocompatible material such as aresin or a metal can be used.

Further, the clip 4 is preferably made of a material having quite goodhinge characteristics as a physical property required particularly forthe deformation function of the deformation portion 42. Morespecifically, a material having a tensile strength of 100 to 500(Kg/cm²), an elongation of 50 to 800% and a tensile modulus of 5 to 25(×10³ Kg/cm²) is preferably used.

Where the physical properly values specified are satisfied, the clip 4is quite good in hinge characteristics and the deformation portion 42has a desired deformation capability.

The seal portion 41 and the deformation portion 42 which are componentsof the clip 4 are preferably formed integrally from the bioabsorbablematerial described above. Also, the fastener portion 43 is preferablyformed integrally from the same material as that of the seal portion 41and the deformation portion 42.

Further, a lubricating surface treat member such as silicon coating isapplied to the outer surface of the clip 4 formed from the bioabsorbablematerial to reduce the resistance of the clip 4 upon insertion into aliving organism so as to facilitate arrangement of the clip 4 into aliving organism. Further, if an X-ray contrast agent is mixed into amaterial for forming the clip 4 or is coated on the surface of the clip4, when the clip 4 is disposed into a living organism, the position ofthe clip 4 can be observed or otherwise determined under an X-ray image.

It is to be noted that the clip 4 used in the disclosed device is notlimited to the clip 4 having the configuration described above. Examplesof other configurations of the clip are shown in FIGS. 3( a)-(c), FIGS.4( a) and 4 (b) and FIG. 5. The following description of thesealternatives addresses primarily the differences relative to the clip 4described above and shown in FIG. 2. A detailed description of thefeatures associated with these alternative configurations for the clipthat are the same as those already described is not repeated.

In the clip 4 shown in FIG. 3( a), the pawls 431 are formed on only oneside (only on the left side in FIG. 3( a)) of the fastener portion 43.

In the clip 4 shown in FIG. 3( b), the width of the connecting portion44 (length in the direction perpendicular to the plane of the figure)between the seal portion 41 and the deformation portion 42 (fastenerportion 43) is narrower (shorter) than that of the clip 4 describedabove with reference to FIG. 2.

In the clip 4 shown in FIG. 3( c), the length of the fastener portion 43in the longitudinal direction is longer than the clip 4 described abovewith reference to FIG. 2, and the distal end portion of the fastenerportion 43 extends through the slit 424 of the corner portion 421 of thedeformation portion 42.

Further, the width of the connecting portion 44 (length in the directionperpendicular to the plane of the figure) between the seal portion 41and the deformation portion 42 (fastener portion 43) is narrower(shorter) than the clip 4 described above with reference to FIG. 2.

In the clip 4 shown in FIG. 4( a), projections 428, 429 are formed attwo corner portions 426, 427 positioned at the diagonal positions in theleftward and rightward direction in FIG. 4( a), respectively. Theprojection 428 extends along an extension line of a left upper link(side) in FIG. 4( a) forming the deformation portion 42, and theprojection 429 extends along an extension line of a right upper link(side) in FIG. 4( a) forming the deformation portion 42.

When a living body tissue membrane is sandwiched between the deformationportion 42 and the seal portion 41, the subcutaneous tissues can becollected in the proximity of the wound hole by the projections 428,429. Consequently, the wound hole can be closed up with a relativelyhigh degree of certainty.

In the clip 4 shown in FIG. 4( b), the pawls 431 are formed on theopposite sides of the fastener portion 43 in the direction perpendicularto the plane of FIG. 4( b). In other words, the positions of the pawls431 of the fastener portion 43 are displaced 90° with respect to thepositioning of the pawls in the clip 4 described above with reference toFIG. 2.

Further, the width of the connecting portion 44 (length in the directionperpendicular to the plane of the figure) between the seal portion 41and the deformation portion 42 (fastener portion 43) is narrower(shorter) than the clip 4 described above with reference to FIG. 2.

In the clip 4 shown in FIG. 5, in its basic form (basic shape), thefastener portion 43 and the deformation portion 42 are inclined withrespect to the seal portion 41.

In particular, since the body element 2 is inserted in an inclinedrelationship, for example, into a blood vessel by a predetermined anglewith respect to the seal portion 41, the fastener portion 43 and thedeformation portion 42 are inclined with respect to the seal portion 41in a corresponding relationship. In this instance, preferably thefastener portion 43 and the deformation portion 42 are inclined withrespect to the seal portion 41 to such a degree that, when the directionof the blood vessel and the direction of the major side (longitudinaldirection) coincide with each other, the longitudinal direction of thebody element 2 and the direction of the center axis of the fastenerportion 43 substantially coincide with each other.

More particularly, the angle (inclination angle) 8 defined by the centeraxis of the fastener portion 43 and the surface of the seal portion 41on the deformation portion 42 side (the plane in which the surface ofthe seal portion 41 lies) is preferably set to a predetermined valuewithin a range of 30° to 60°. Thus, the wound hole can be closed with arelatively high degree of certainty.

It is to be noted that the shape of the deformation portion of the clip(living body tissue closure) is not limited to a quadrangular shape butmay be some other polygon in the shape of a framework, or may be in theshape of a framework having no angle such as an annular framework or anelliptic framework. Further, the shape of the deformation portion may bea shape different than that in the shape of a framework.

Further, in the clip described above, the number of pawls at thefastener portion of the clip (living body tissue closure) may be onlyone.

A procedure for performing a staunching operation (operation of theliving body tissue closing device 1) using the living body tissueclosing device 1 is described below.

First, the feeding and deformation means 3 is assembled in the mannershown FIG. 6. The stopper 12 is first mounted on the tube body 71 of thepusher tube 7 (e.g., at a position indicated by the broken line in FIG.1), and then the pusher tube 7 is inserted into the covered tube 6 fromthe proximal end side of the covered tube 6. The stopper 12 is thenpositioned between the hub 72 of the pusher tube 7 and the hub 62 of thecovered tube 6.

In addition, as shown in FIG. 1, the thread 8 is threaded into the slit424 of the deformation portion 42 of the clip 4 from the upper side inFIG. 1, is threaded through the hole 432 of the fastener portion 43, andis further threaded through the slit 424 from the lower side in FIG. 1.

Further, as shown in FIG. 6, the guide wire 11 is inserted into thepusher tube 7 from the proximal end side of the pusher tube 7 and ispassed through the slit 424 of the deformation portion 42 of the clip 4,the hole 425 of the deformation portion 42 and the hole 411 of the sealportion 41.

Then, the opposite end portions of the thread 8 are inserted into thepusher tube 7 from the distal end side of the pusher tube 7 and drawnout from the proximal end portion of the pusher tube 7.

Further, the deformation portion 42 of the clip 4 is deformed, and thedeformed deformation portion 42 is inserted into (mounted at) thecovered tube 6 from the distal end side of the covered tube 6.

Then, in this state, the thread anchoring cap 9 is mounted on the hub 72of the pusher tube 7, and the rib 723 of the hub 72 is engaged with thegroove 92 of the thread anchoring cap 9. Consequently, the opposite endportions of the thread 8 are sandwiched between the thread anchoring cap9 and the hub 72, and are retained at the proximal end portion of thepusher tube 7. The assembly of the feeding and deformation means 3 isthus completed.

For the sheath 5, it is possible to use a sheath dwelling after therapy(PCI) or after treatment of a diagnosis (CAG) in which a catheter isused. The distal end portion of the sheath 5 is inserted in a bloodvessel.

Then, the feeding and deformation means 3 is inserted into thethrough-hole 51 of the sheath 5 from the proximal end side of the sheath5 as shown in FIG. 6, and the hub 62 and the hub 52 are fitted with eachother, with the rib 622 of the hub 62 engaging the groove 53 of the huh52 as shown in FIG. 7. Consequently, the seal portion 41 of the clip 4projects from the distal end portion of the sheath 5 and is insertedinto the blood vessel.

Thereafter, the body element 2 is moved slowly in a direction in whichit is pulled out from the wound hole as shown in FIG. 8 until the woundhole and a surrounding portion of the wound hole are covered from theinner side of the blood vessel wall by the seal portion 41 of the clip 4to position the seal portion 41.

Consequently, the deformation portion 42 and the fastener portion 43 ofthe deformation portion 42 individually move to the outer side of theblood vessel. Further, the seal portion 41, having been substantiallyparallel to the fastener portion 43, is guided as it approaches thewound hole by the guide wire 11 so that it is restored towards anorientation in which it is generally perpendicular to the fastenerportion 43. Consequently, the wound hole and the surrounding portion ofthe wound hole are readily and reliably covered.

Then, the stopper 12 positioned between the hub 62 of the covered tube 6and the hub 72 of the pusher tube 7 is removed, and the covered tube 6or the sheath is moved in a direction in which it is pulled away fromthe wound hole until the hub 72 and the hub 62 are fitted with eachother, with the rib 722 of the hub 72 engaging the groove 623 of the hub62 as shown in FIG. 9.

Thereafter, the thread anchoring cap 9 is removed from the hub 72 of thepusher tube 7 so that the guide wire 11 is also pulled off as shown inFIG. 10. Then, while the thread 8 is pulled a little so that tension isapplied to the thread 8 (while the fastener portion 43 of the clip 4 isbeing pulled), the body element 2 is pushed in a direction in which itis inserted into the wound hole to deform the deformation portion 42 ofthe clip 4 toward the second form (deformed condition). Then, thisoperation is continued until the staunching operation is completed asshown in FIG. 11.

Consequently, the deformation portion 42 covers the wound hole and thesurrounding portion of the wound hole from the outer side of the bloodvessel wall while the seal portion 41 covers the wound hole and thesurrounding portion of the wound hole from the inner side of the bloodvessel wall. Thus, the blood vessel wall is sandwiched between the sealportion 41 and the deformation portion 42 to close the wound hole.Predetermined ones of the pawls 431 of the fastener portion 43 engagethe corner portion 421 of the deformation portion 42 to retain thedeformation portion 42 in the second form or deformed condition.

Finally, the body element 2 and the thread 8 are pulled off while theclip 4 remains disposed (dwelling) in the living organism. Thestaunching operation is thus completed.

As described above, according to the living body tissue closing device 1described above, the safety is relatively high, and the staunchingoperation can be performed quite readily and with relative certainty fora wound hole formed in a living body tissue membrane such as a bloodvessel wall. In other words, the wound hole can be closed (sealed)rather readily and with certainty, and the bleeding can be staunchedcompletely.

A second embodiment of a living body tissue closing device is describedbelow with reference to FIGS. 13-17. It is to be noted that, in FIG. 14,a pusher tube 7 is schematically shown by a broken line.

Further, for the convenience of description, in FIGS. 13, 16 and 17, theleft lower side is referred to as the “distal end” and the right upperside is referred to as the “proximal end”. Further, in FIGS. 14 and 15,although the upper side of the living body tissue closing device as awhole is the “proximal end” and the lower side is the “distal end”, asregards a clip (living body tissue closure) 4, the upper side in thefigures is referred to as the “distal end” and the lower side isreferred to as the “proximal end”.

The following description primarily describes differences between theliving body tissue closing device 1 of the second embodiment relative tothe first embodiment described above. A detailed description of featurescommon to both embodiments is not repeated.

As shown in FIGS. 13 and 14, the living body tissue closing device 1 ofthe second embodiments does not utilize the guide wire 11.

The clip (living body tissue closure) 4 includes a seal portion 41, adeformable deformation portion 42 adjacent the seal portion 41, afastener portion 43 for retaining, when the deformation portion 42enters a state of a predetermined form between a contracted form and anexpanded form, the deformation portion 42 in the state of predeterminedform, and a connecting portion 44 connecting the seal portion 41 and thedeformation portion 42 to each other. The seal portion 41, thedeformation portion 42, the fastener portion 43 and the connectingportion 44 are preferably formed integrally in one piece from the samematerial.

The seal portion 41 is a member having a flat face portion (flat face)for closely contacting a surrounding portion of a wound hole (portionincluding the wound hole) of a living body tissue membrane from one side(inner surface) of the living body tissue membrane to cover the woundhole and the surrounding portion of the wound hole. In the illustratedembodiment, the seal portion is plate-shaped.

The face (upper side face in FIG. 14) of the seal portion 41 to whichthe deformation portion 42 is connected is a substantially flat face.

The deformation portion 42 has a shape like a pantograph and isconnected (coupled) to a substantially middle portion of the sealportion 41 through the connecting portion 44. In particular, thedeformation portion 42 possesses a framework shape and is adapted to bedeformed between a contracted form, in which it extends in a directionsubstantially perpendicular to the seal portion 41 (perpendicular to areference plane, for example the surface of the seal portion 41 on thedeformation portion 42 side) and contracted in a direction substantiallyparallel to the seal portion 41, and an expanded form in which itextends in a direction substantially perpendicular to the seal portion41 and is expanded in a direction substantially parallel to the sealportion 41. Accordingly, the deformation portion 42 can be deformed fromthe basic form (basic shape) shown in FIG. 14( b) to an arbitrary formbetween the contracted form and the expanded form described above suchas a first form shown in FIG. 14( a) wherein it can pass through a woundhole and a second form shown in FIGS. 14( c) and 14(d) wherein thedeformation portion 42 cooperates with the seal portion 41 to sandwichthe living body tissue membrane therebetween from the other side (outersurface) of the living body tissue membrane. The deformation portion 42cooperates with the seal portion 41 to sandwich the living body tissuemembrane therebetween, with the seal portion positioned on one side ofthe living body tissue membrane and the deformation portion positionedon the other side of the living body tissue membrane so that the sealportion 41 is held to or retained at the one side of the living bodytissue membrane. Accordingly, the deformation portion 42 forms aretainer cooperating with the seal portion 41 to sandwich a living bodytissue membrane from the other side of the living body tissue membraneand retain the seal portion 41 to the one side.

Here, in the present embodiment, the deformation portion 42 has aquadrangular annular shape in which a belt-like member includes fourbends (a polygonal annular shape). In particular, the deformationportion 42 includes four links formed integrally with each other andarranged in a quadrangular shape (shape of a quadrangular framework)having four corners which can generally bend like a hinge. Thedeformation portion 42 includes two corner portions 421, 422 positionedat diagonal positions in the upward and downward direction in FIG. 14.The corner portion 422 on the lower side (seal portion 41 side) in FIG.14 is connected to substantially the middle portion of the seal portion41 through the connecting portion 44 and thus is a fixed portion whichcannot move with respect to the upper side end portion of the connectingportion 44 in FIG. 14 or the fastener portion 43.

The deformation portion 42 is deformed such that the corner portion 421and the corner portion 422 move toward and away from each other. Inparticular, the deformation portion 42 can be deformed into expanded andcontracted states in two directions perpendicular to each other and canrock (turn around an axis of turning motion) with respect to the sealportion 41. The connecting portion between the seal portion 41 and thecorner portion 422 of the deformation portion 42 (the connecting portion44) possesses flexibility (elasticity), and the seal portion 41 isturned as the connecting portion 44 is bent (resiliently deformed).

The upper face of the corner portion 421 (surface on the opposite sideto the seal portion 41) on the upper side (on the opposite side to theseal portion 41) in FIG. 14 is formed as a curved convex face. Asubstantially H-shaped slit 424 is formed in the corner portion 421 asshown in FIG. 14. The slit 424 forms an opening extending through thedeformation portion 42 in the shape of a framework, and at least part ofthe fastener portion 43 is adapted to be inserted (fitted) into the slit424. That is, the fastener portion 43 can be accepted in the slit 424.

A pair of projections 46, 46 project from the outer side of thedeformation portion 42 on the seal portion 41 side that is in theproximity of the corner portion 422. The projections 46 project towardthe seal portion 41 side. Each of the projections 46 extends in awidthwise direction of the deformation portion 42, and a portion of eachprojection on the seal portion 41 side has a pointed end.

The length of each projection 46 in the widthwise direction of thedeformation portion 42 is set substantially equal to the width of thedeformation portion 42.

The projections 46 are positioned so that during use of the tissueclosure, the projections are located in the proximity of the wound holeclosed with the living body tissue closure 4, and the wound hole istightened strongly by the projections 46. Consequently, the bleeding canbe staunched or stopped with a relatively high degree of certainty.

Further, even if a failure occurs in the staunching operation (forexample, when the blood vessel wall or the subcutaneous tissue is sohard that the deformation portion 42 cannot be expanded or the like) andmanual astriction is required and a force in the direction in which theliving body tissue closure 4 is inserted transcutaneously into the bloodvessel is applied to the living body tissue closure 4 by the manualastriction, the projections 46 help prevent the living body tissueclosure 4 from dropping into the blood vessel. This enhances the safety.

In the illustrated embodiment, the connecting portion 44 isplate-shaped. The connecting portion 44 spaces the seal portion 41 andthe corner portion 422 of the deformation portion 42 away from eachother by a predetermined distance.

In the illustrated embodiment, the fastener portion 43 is alsoplate-shaped. The fastener portion 43 is positioned within the frameworkof the deformation portion 42 and is connected at its proximal endportion (lower side end portion in FIG. 14) to the inner surface of thedeformation portion 42. The fastener portion 43 is thus connected to theseal portion 41 through the corner portion 422 and the connectingportion 44. The fastener portion 43 can rock (turn or pivot about asingle axis of turning/pivoting motion) together with the deformationportion 42 with respect to the seal portion 41. In other words, the sealportion 41 is able to pivot or turn with respect to the deformationportion 42 and the fastener portion 43 about a single axis (i.e., therelative pivoting/turning movement between the seal portion 41 on theone hand and the deformation portion 42 and fastener portion 43 on theother hand is limited to pivoting/turning movement in a single plane).

The pawls 431 are formed on one side (right side) of the fastenerportion 43 in the leftward and rightward direction in FIG. 14. A number(two in the illustrated example) of such pawls 431 are juxtaposed in aspaced relationship by a predetermined distance from each other alongthe longitudinal direction (upward and downward direction in FIG. 14) ofthe fastener portion 43.

It is to be noted that the projections 46 of the deformation portion 42of the clip 4 in terms of for example, the shape, position and numberare not limited to that described above. FIG. 15 illustrates anotherexample in which each of the projections 46 has, as viewed in plan (asviewed from the upper side in FIG. 15), a substantially triangular shapewhich is pointed toward a central portion of the deformation portion 42in the widthwise direction.

As shown in FIGS. 14 and 16, the seal portion 41 of the clip 4 ispreferably set such that the length L (length in the longitudinaldirection) of the longest portion thereof is smaller than the innerdiameter (diameter) R of a portion of a living organism lumen (forexample, a blood vessel) in which the clip 4 is inserted. Moreparticularly, the length of the longest portion of the seal portion 41preferably is equal to or less than 6 mm, more preferably equal to orless than 5 mm, and is further preferably approximately 3.5 to 4.5 mm.

Consequently, the seal portion 41 of the clip 4 is permitted to turn(displace) freely with respect to the deformation portion 42 and suchadvantages are achieved.

As shown in FIG. 16, where a blood vessel is branched intermediately onthe distal end side with respect to a wound hole in the blood vesselwall, the seal portion 41 of the clip 4 sometimes interferes with thebranched portion of the blood vessel part of the way during theoperation in which the body element 2 is moved in a direction in whichit is pulled out from the wound hole while the wound hole and asurrounding portion around the wound hole is covered from the inner sideof the blood vessel wall with the seal portion 41 of the clip 4 (duringpositioning of the seal portion 41).

At this time, as shown in FIG. 17, the seal portion 41 can turn withrespect to the deformation portion 42 and be brought away frominterfering with the branched portion of the blood vessel. Consequently,the seal portion 41 can be prevented from being caught or being stuck bythe branched portion of the blood vessel.

Further, since the seal portion 41 can turn around only one axis ofpivoting motion (i.e., is limited to pivoting movement in a singleplane) with respect to the deformation portion 42 (being bent in onlyone fixed direction), the seal portion 41 can be moved readily andstably along the route of the blood vessel. Finally, the seal portion 41can be positioned at an optimum position with respect to the wound holeof the blood vessel wall, for example can be positioned such that thelongitudinal direction of the seal portion is in substantially parallelrelation to the route of the blood vessel. Consequently, the bleedingcan be staunched with a relatively high degree of certainty.

Further, since positioning of the seal portion 41 can be performed onlyby inserting the living body tissue closure 4 once into the deepestportion of the blood vessel on the central side and then moving the bodyelement 2 in a direction in which it is pulled off from the wound hole,the staunching operation can be performed very readily and withcertainty.

With the living body tissue closing device 1, similar effects to thoseof the living body tissue closing device 1 of the first embodimentdescribed hereinabove can be achieved.

A third embodiment of a living body tissue closing device will now bedescribed with reference to FIGS. 18-20. In FIGS. 18-20, the proximalend side of each of the covered tube 6 and the pusher tube 7 is notshown.

For the convenience of description, in FIGS. 18-20, the left lower sideis referred to as the “distal end” and the right upper side is referredto as the “proximal end”. Regarding the clip (living body tissueclosure) 4, the upper side in the figures is referred to as the “distalend” and the lower side is referred to as the “proximal end”.

The following description primarily describes differences between theliving body tissue closing device 1 of the third embodiment relative tothe second embodiment described above. A detailed description offeatures common to both embodiments is not repeated.

As shown in FIG. 18, the living body tissue closing device 1 includes athread (string member) 13 serving as deformation portion pulling meansfor pulling the deformation portion 42 of the clip 4 to the proximal endside of the feeding and deformation means (arrangement device) 3.

In a state in which the thread 13 is threaded through the deformationportion 42 and suspended on the corner portion 421, the opposite endportions thereof are drawn out from the proximal end side of the coveredtube 6 and the pusher tube 7 to the outside. The thread 13 forms aretainer for retaining (accommodating) the deformation portion 42 of theclip 4 at the distal end portion of the covered tube 6 (on the distalend side of the feeding and deformation means 3).

The covered tube 6 has a contacting portion 63 provided at the distalend portion of the tube body 61. The contacting portion 63 isplate-shaped and projects in the direction of the distal end from thedistal end of the tube body 61. That is, in the illustrated embodiment,the contacting portion 63 is formed by a distally extending extension ofa part of the wall portion forming the tube body 61.

In the disclosed and illustrated example, the contacting portion 63 ispreferably formed such that it satisfies the relationship a >L, where ais the length of the contacting portion 63 in the longitudinal directionand L is the length in the longitudinal direction of the longest portionof the deformation portion 42.

The contacting portion 63 forms a displacement means for displacing theseal portion 41 of the clip 4 so that it extends substantially parallelto the longitudinal direction (axial direction) of the feeding anddeformation means (arrangement device) 3.

With this embodiment of the living body tissue closing device 1, theclip 4 inserted in a blood vessel (living organism lumen) can berecovered from within the blood vessel part of the way through thestaunching operation.

The following is a description of the operation of the living bodytissue closing device 1 is a situation when the clip 4 is positionedsuch that the seal portion 41 of the clip 4 is positioned within a bloodvessel while the deformation portion 42 and the fastener portion 43 arepositioned outside the blood vessel as shown in FIG. 18.

First, the thread 13 is pulled to the proximal end side of the feedingand deformation means 3 to pull the deformation portion 42 of the clip 4to the proximal end side and deform the deformation portion 42 so thatthe deformation portion 42 is expanded in a direction substantiallyperpendicular to the seal portion 41 and is contracted in a directionsubstantially parallel to the seal portion 41 (so as to be closed) asshown in FIG. 19( a).

Then, while the thread 13 is pulled to the proximal end side of thefeeding and deformation means 3 to pull the deformation portion 42 ofthe clip 4 to the proximal end side, the covered tube 6 is pushed out oradvanced in the distal direction until the deformation portion 42 isretained (accommodated) in the proximal end portion of the covered tube6 as shown in FIG. 19( b).

The feeding and deformation means 3 is then moved in the distaldirection so that the proximal end portion of the covered tube 6 entersinto the blood vessel until the seal portion 41 is positioned at aposition at which the seal portion 41 of the clip 4 can turn as shown inFIG. 19( c). That is, the seal portion 41 is moved away from the innersurface of the blood vessel wall in which the wound hole is formed asshown in FIG. 19( c).

Thereafter, while the thread 13 is being pulled to the proximal end sideof the feeding and deformation means 3 (while the deformation portion 42of the clip 4 is being pulled to the proximal end side), the coveredtube 6 is pushed out (propelled) in the distal direction as shown inFIG. 20( a). Consequently, the face of the seal portion 41 on thedeformation portion side contacts the contacting portion 63. The sealportion 41 thus turns (is displaced) with respect to the deformationportion 42 until it comes to a position in which it extendssubstantially parallel to the longitudinal direction (axial direction)of the covered tube 6 (feeding and deformation means 3).

Then, the covered tube 6 is turned by approximately 180° so that theupper side end portion of the seal portion 41 in FIG. 20( b) can bereadily pulled out from the wound hole or the wound of the blood vessel.

Finally, the feeding and deformation means 3 and the clip 4 are pulledout from the wound hole or wound of the blood vessel as shown in FIG.20( c). By the procedure described above, the clip 4 is recovered fromwithin the blood vessel. Thereafter, predetermined treatment such asmanual astriction can be performed.

With the living body tissue closing device 1 of the third embodiment,similar effects to those of the living body tissue closing device 1 ofthe second embodiment described hereinabove are achieved.

Further, even if the deformation portion 42 of the clip 4 does not open(for example, when the blood vessel is hard due to calcification, whenthe subcutaneous tissue has a hard trace by re-punctures or the like)and failure in staunching the bleeding occurs, the clip 4 inserted inthe blood vessel can be readily recovered and with certainty from withinthe blood vessel. Thereafter, ordinary manual astriction, for example,can be preformed. Consequently, the safety is enhanced significantly.

The living body tissue closing device disclosed herein by way of severalembodiments makes it possible to readily perform a staunching operationfor a wound hole formed in a living body tissue membrane such as a bloodvessel wall with a relatively high degree of certainty and safety. Thewound hole can be closed rather readily and with relative certainty,with the bleeding staunched or stopped completely.

As described above, the clip 4 preferably possesses certaincharacteristics which are useful in the context of the disclosed usage.For example, it has been mentioned that the clip preferably possessesgood hinge characteristics. The material from which the clip 4 is madeis also a consideration. Collagen has been used for years for surgicaloperations and the like as a haemostatic material. Collagen is generallyknown to promote blood coagulation by activating the blood platelet tostop bleeding from the blood vessel. While collagen is well suited tostopping bleeding, it has been found that a thrombus can be formed bycontact of collagen and blood inside the blood vessel, thus causing avascular obstruction when collagen is inserted in the blood vessel. Thusconcerns might arise using a collagen clip in the tissue closing device.

An experiment was conducted using a clip made of polydioxanone (PDO).The experiment was conducted on a pig weighing approximately 50 kg. Thefemoral artery of the pig was exposed by an incision made around thethigh of the pig while the pig was under continuous inhalationanesthesia. A sheath was placed in the exposed femoral artery. Twohundred units/kg of heparin was administered as an anti-coagulationagent. A clip made of PDO was introduced through the sheath and placedin the artery. The bleeding from the puncture hole made by the sheathwas stopped, and after confirming that the bleeding had stopped, theincision in the thigh was sutured. Following completion of suturing, thepig was released from the inhalation anesthesia.

Twelve days after placement of the clip, the pig was sacrificed by bloodletting under continuous inhalation anesthesia. The femoral artery inwhich the clip had been placed was removed and was subject to formalinfixation, and the formalin-fixed femoral artery was pathologicallyobserved. The results of the observation showed no thrombosis formation.

It has thus been found that PDO, which has been previously used forsuturing general soft tissues including infant cardiovascular tissues,is a particularly preferred material for the clip 4 used in the tissueclosing device in that such material reduces the possibility of theformation of a thrombosis at the site where the clip contacts the blood,thus reducing the likelihood of a vascular obstruction. The clip made ofthis material can thus be inserted in the blood vessel through aprocedure sheath that is kept in place in the blood vessel after beingpreviously used for catheter surgery.

An experiment was conducted to compare characteristics of a clip havinga seal portion made of PDO and a commercially available vascular closuredevice that includes a seal portion made of a copolymer of polyglycolicacid and polylactic acid and a collagen plug that is attached to theseal portion with thread. The seal portion of the commercially availableproduct was kept in about 50 ml of a phosphate buffer solution (pH 7.41)in a screw cap test tube. After a cap of the screw cap test tube wasclosed, the tube was placed in an oven at 37° C. On days 7 and 14, andexternal observation and a strength measurement were performed. A sealportion 41 made of PDO was similarly tested. The strength measurement inthis example measured the destruction strength by pulling the upper topportion of the deformation portion while the seal portion was fixed. Theresults of this experiment are shown in the table below.

Day 7 Day 14 External External Samples Observation Strength ObservationStrength Commercially Swollen and Not Deformed Not available productsoftened Measured Measured Clip having Seal No Change 3.5 kgf No Change3.2 kgf Portion made of PDO

The seal portion of the commercially available product kept dipped in aphosphate buffer solution (pH 7.4) at 37° C. caused the seal portion toswell and deform on day 7 and lose its strength significantly. On theother hand, the seal portion made of PDO, and smaller in size than thatof the commercially available product, did not swell while kept dippedin a phosphate buffer solution (pH 7.4) at 37° C., and maintained itsstrength. It has been demonstrated that the seal portion made of PDOmaintains relatively secure hemostatic capability more safely during thetime period that the seal portion placed in the blood vessel isencapsulated to be stable (approximately 1 week).

Another aspect of the tissue closure which has been studied is the sizeof the seal portion 41 of the clip 4. Since the seal portion isintroduced through a sheath, the width of the seal portion shouldpreferably be one that allows the clip to be moved or transited insidethe sheath. The width of the seal portion 41 refers to the dimension ofthe seal portion perpendicular to the length L of the seal portion shownin FIG. 18. It has been found that the width of the seal portion 41should preferably be one-half or less of the length of the innercircumference of the sheath. For example, when the sheath possesses asize used for a 6 French (Fr) catheter (i.e., the size of the sheath isgreater than the size of the catheter inserted in the sheath), the widthof the seal portion should preferably be 3.5 mm or less. When the sheathpossesses a size used for a 7 Fr catheter, the width should preferablybe 4.0 mm or less. When the sheath possesses a size used for a 8 Frcatheter, the width should preferably be 4.5 mm long or less. Note that1 French (Fr) is equal to 0.33 mm (0.013 inches) for the outer diameterof a tube. By way of example, the inner diameter of the sheath used fora 6 Fr catheter is 2.22 mm.

Alternatively, the sheath into which the seal portion 41 is introducedmay be fixed to its sheath hub by a hollow pin that is axially insertedor embedded in the hub for the sheath (i.e., the proximal end of thesheath and the distal end of the hub are fitted to one another, and apin with an increasing outer size is fitted into the distal end of thehub and the proximal end of the sheath to fix the sheath and hubrelative to one another). In such a situation, the width of the sealportion should preferably be equal to or less than the inner diameter ofthe pin. For example, when the sheath possesses a size used for a 6 Frcatheter, the width of the seal portion should preferably be 2.8 mm orless. When the sheath possesses a size used for a 7 Fr catheter, thewidth should preferably be 3.2 mm long or less. When the sheathpossesses a size used for a 8 Fr catheter, the width should preferablybe 3.7 mm long or less.

The length of the seal portion of the clip is another consideration. Thelength of the seal portion refers to the dimension identified as L inFIG. 18. The length of the seal portion should be smaller than the innerdiameter of the blood vessel where the blood staunching operation isperformed so that the seal portion does not damage the blood vessel walland so that the seal portion does not become stuck at a vascularbifurcation when the seal portion moves inside the blood vessel.

The length of the seal portion should also be larger than the outerdiameter of the sheath so that the seal portion is able to block orcover the puncture hole made by the sheath that is inserted in the bloodvessel. In addition, the seal portion should be dimensioned so that itis not pulled out from the blood vessel by the force of the operator(approximately 400 gf) that is applied by the operator to determine thatthe seal portion is positioned around the puncture hole of the bloodvessel.

The length of the seal portion should thus preferably be equal to orgreater than the outer diameter of the sheath, and equal to or less thanthe inner diameter of the blood vessel. For example, when the sheathpossesses a size used for a 6 Fr catheter, the length of the sealportion should preferably be equal to or greater than 2.5 mm, and equalto or less than 8.0 mm. When the sheath possesses a size used for a 7 Frcatheter, the length of the seal portion should preferably be equal toor greater than 2.9 mm, and equal to or less than 8.0 mm. When thesheath possesses a size used for a 8 Fr catheter, the length of the sealportion should preferably be equal to or greater than 3.2 mm, and equalto or less than 8.0 mm long or less.

An experiment was performed on clips with sealing portions of differentdimensions. A sheath was placed in the femoral artery of a cadaver andthe clips were introduced through the sheath into the blood vessel. Foreach clip, the clip was pulled until a predetermined resistance wasfelt. Then, it was confirmed whether the seal portion of the clip wascontacting the blood vessel at the puncture hole made by the sheath orwhether instead the seal portion of the clip was stuck inside the bloodvessel.

After the positioning was completed, the portion of the clip outside theblood vessel was attached to a spring gage and a pulling force of 400 gfwas applied to the clip. It was then determined whether the clip waspulled out of the blood vessel upon applying this pulling force. Theresults of the experiment for clips with sealing portions of differentdimensions are set forth in the table below.

Sheath for Whether or Whether or not the Receiving Length not the clipseal portion was a Catheter Width of of the was stuck pulled out upon ofNoted the Seal Seal inside the pulling with a Size Portion Portion bloodvessel force of 400 gf 6Fr 2.7 mm 10 mm  Yes Not observed (Determined tobe unnecessary to observe) 6Fr 3.0 mm 6 mm No Not observed (Determinedto be unnecessary to observe) 6Fr 2.8 mm 5 mm No Not pulled out 6Fr 2.8mm 4 mm No Not pulled outSince the outer diameter of the sheath used for a 6 Fr catheter is 2.6mm, a seal portion with a length of 3 mm long was determined to beobviously pulled out and was thus not observed. That is, because thedifferential between the outer diameter of the sheath (i.e., the size ofthe wound hole) and the 3 mm length of the seal portion is quite small,it was determined that the seal portion would obviously be pulled out.Also, as it was observed that the seal portion with a length of 5 mm wasnot pulled out, it was determined that seal portions with a length of 6mm and a length of 10 mm would also not be pulled out and so were notobserved.

As a result of the experiment, it has been found that when the sealportion is introduced through a sheath having a size for 6 Fr-8 Frcatheters, and is intended to be positioned inside the femoral artery,the length of the seal portion should preferably be equal to or greaterthan 4.0 mm, and equal to or less than 6.0 mm.

Another consideration involving the sealing portion is determining asize of the sealing portion that will prevent the clip from becomingcaught in and hurting the intima of the blood vessel. When the sealportion of the clip is moved inside the blood vessel, it is desirablethat the seal portion not get stuck in the blood vessel, while stillbeing able to be positioned around the puncture hole such that when theseal portion is pulled with a predetermined force, the seal portion isnot pulled out of the puncture hole.

The seal portion of the clip includes a front end portion (the endnearer to the heart or on the upstream side of blood flow) and a rearend portion. The front end portion of the seal portion refers to the endportion that is nearer to the heart and on the upstream side of bloodflow. The rear end portion refers to the end portion that is nearer tothe peripheral (i.e., the end portion farther away from the heart) andon the downstream side of blood flow. It has been found that if both endportions of the seal portion are of the same length, the front endportion of the seal portion can become caught and hurt the intima of theblood vessel, thus causing trauma, damage and/or bleeding in the bloodvessel. It has been discovered that this may be addressed by elongatingor increasing the length of the front end portion of the seal portionmore than the rear end portion of the seal portion. The reasons arethought to be as follows. The distal end of the sheath used in theheart-catheterization surgery is placed in the blood vessel facing theheart, and the puncture cavity of the subcutaneous tissue slopes alongthe vessel as shown schematically in FIG. 21. When the seal portion ispulled together with the sheath to position the seal portion to theblood vessel, the connecting portion 44 of the seal portion pushes andopens the puncture hole of the blood vessel toward the end nearer to theperipheral. Then, since a torque which rotates the seal portion occurs,the front end portion moves up and the rear end portion moves down.Accordingly, there is a likelihood that the front end portion of theseal portion will be caught in and hurt the blood vessel wall.

It is thought that making the length of the front end portion of theseal portion longer than the rear end portion, making the front endportion of the seal portion a certain length (minimum length) andenlarging the contact area of the front end portion to the vessel wallcould help avoid damage to the blood vessel surface.

An experiment was performed in which a sheath was placed in the femoralartery of a cadaver. A clip was introduced through the sheath into theblood vessel. The clip was clipped to the puncture hole made by thesheath (i.e., the clip was operated to sandwich the blood vessel wallbetween the seal portion and the deformation portion) using theprocedures discussed above in connection with the several disclosedembodiments. After removing the blood vessel to which the clip wasapplied, the status of the inner surface of the blood vessel in the areaof the seal portion was observed. This experiment was conducted with twoclips, one having a seal portion length of 4 mm with the front and rearend portions each being 2 mm in length, and another having a sealportion length of 5 mm with the front end portion having a length of 3mm and the rear end portion having a length of 2 mm. The results are setforth in the table below.

Whether or not the front Length of the end portion of the seal Length ofthe Front/Rear End portion gave trauma to the Seal Portion Portionsurface of the blood vessel 4 mm 2 mm/2 mm Yes 5 mm 3 mm/2 mm No

The results of the experiment confirmed that damage to the blood vesselsurface could be lessened or avoided by making the length of the frontend portion of the seal portion longer than the rear end portion, makingthe front end portion of the seal portion a certain length (minimumlength) and enlarging the contact area of the front end portion to thevessel wall. It was found that the length of the front end portion ofthe seal portion is preferably equal to or greater than 3 mm.

Another aspect of the clip to be considered involves the length of theoutside portion of the clip from the blood vessel. The length of theoutside portion of the clip from the blood vessel (the length of thedeformation portion) should preferably be shorter than that of thepuncture cavity from the skin to the blood vessel in order to avoidinfection or breakdown of the clip, since the outside portion is exposedto the outside environment of the body. The length of the outsideportion of the clip from the blood vessel is preferably equal to or lessthan 20 mm, more preferably equal to or less than 10 mm, to shorten thedistance for the blood vessel to travel by pulling the clip (i.e., themoving distance of the deformation portion for deformation) uponcarrying out the clipping operation described above in connection withthe several disclosed embodiments. The moving distance of thedeformation portion refers to the distance between the position of theseal portion shown in FIG. 9 and the position of the seal portion shownin FIG. 11, because as the deformation portion is deformed during theclipping operation shown in FIGS. 9-11, the movement of the seal portion41 causes the blood vessel to be pulled up.

A further consideration that arises when positioning the clip in theblood vessel during the clipping operation is the retaining force thatthe covered tube applies to retain the deformation portion. If thisretaining force, involving the frictional force between the deformationportion 42 and the covered tube 6, is excessively small, the deformationportion 42 can draw out easily from the covered tube. On the other hand,if the retaining force is excessively large, it will be difficult todraw the deformation portion 42 out of the covered tube 6.

An experiment was conducted to determine the force required to pull theseal portion out of the blood vessel. In this experiment, a sheath wasplaced in the femoral artery of a cadaver and a clip was introducedthrough the sheath into the blood vessel. The clip was positioned at thepuncture hole made by the sheath by the procedures described above.After positioning the clip, the portion of the clip outside the bloodvessel was attached to a spring gage. The spring gage was then pulledand the force was measured when the seal portion of the clip was pulledout of the blood vessel. The results are shown in the table below.

Force for Length Length of the pulling the seal of the Front/Rearportion out of Sheath Placement Seal Portion End Portion the bloodvessel Exposed blood vessel 5 mm 3 mm/2 mm 1.2 kgf Subcutaneous blood 5mm 3 mm/2 mm 2.2 kgf vessel

It was demonstrated that the seal portion was pulled out of the bloodvessel when the seal portion was pulled away from the blood vessel witha force of 2.2 kgf or more after positioning of the seal portion.Therefore, the retaining force that the covered tube 6 applies to retainthe deformation portion (i.e., the force by which the deformationportion is pulled out from the covered tube 6) should preferably be lessthan 2.2 kgf, more preferably less than 1.2 kgf, to reduce damage to theblood vessel with the seal portion and to expand the range ofapplication.

Other properties of the clip that have been found to be of significanceinclude the breaking force of the connecting portion between the sealportion and the deformation portion. Here, the breaking force of theconnecting portion should preferably be 2.0-5.0 kgf/mm². In addition,the force required to deform the deformation portion should preferablybe 0.3-1.0 kgf (0.2-0.3 mm thickness of the hinges forming thedeformation portion)

It is to be understood that the each of the embodiments described abovecan be configured to include features from the other embodiments.

Also, the fastener portion 43 may be a filament that passes through fromthe inner side of the deformation portion 42 to the corner portion 421.The filament may fix the deformation portion 42 by a knot on the upperside of the corner portion 421. Also, the seal portion 41 may have sucha structure (configuration) as that of the deformation portion 42described hereinabove.

The description above describes principles and preferred embodiment ofthe disclosed living body tissue closing device. However, the inventionwhich is intended to be protected is not to be construed as limited tothe particular embodiments disclosed. The embodiments described hereinare to be regarded as illustrative rather than restrictive. Variationsand changes may be made by others, and equivalents employed, withoutdeparting from the spirit of the present invention. Accordingly, it isexpressly intended that all such variations, changes and equivalentswhich fall within the spirit and scope of the present invention asdefined in the claims, be embraced thereby.

1. A tissue closure for closing an opening penetrating a blood vesselmembrane, comprising: a seal portion possessing a flat face portion forcovering, from an inner side of the blood vessel membrane, the openingpenetrating the blood vessel membrane and a surrounding portion of theopening; a deformation portion configured to expand and contract in twosubstantially perpendicular directions; a fastener portion to retain thedeformation portion in a predetermined form; the deformation portioncomprising an opening portion movable relative to the fastener portionand adapted to receive the fastener portion; a connecting portionconnecting the seal portion and the deformation portion, the connectingportion consisting of a single bendable plate so that the connectingportion permits pivoting motion of the seal portion in only a singleplane; and the deformation portion comprising a fixed portion integratedwith the fastener portion and immovable relative to the fastenerportion, the deformation portion being configured to cooperate with theseal portion to sandwich the blood vessel membrane between the sealportion at the inner side of the blood vessel membrane and thedeformation portion at an outer side of the blood vessel membrane. 2.The tissue closure according to claim 1, wherein the seal portion andthe deformation portion are integrally molded in one piece from the samematerial.
 3. The tissue closure according to claim 1, wherein thedeformation portion possesses a framework shape.
 4. The tissue closureaccording to claim 1, wherein the deformation portion possesses aquadrangular shape formed integrally from four links and is deformablesuch that two corner portions at diagonally opposite positions of thequadrangular shape move toward and away from each other.
 5. The tissueclosure according to claim 4, wherein the fastener portion isconstructed to control a distance between the two corner portions. 6.The tissue closure according to claim 4, wherein the fastener portion isconstructed to control a distance between the two corner portions to anyone of a plurality of different distances.
 7. The tissue closureaccording to claim 1, wherein the fastener portion is constructed tocontrol a degree of deformation of the deformation portion to one of aplurality of deformed states.
 8. The tissue closure according to claim1, wherein the fastener portion is constructed to allow deformation ofthe deformation portion in a direction in which a degree of deformationof the deformation portion increases while also preventing deformationof the deformation portion in another direction in which the degree ofdeformation of the deformation portion decreases.
 9. The tissue closureaccording to claim 1, wherein the fastener portion is positioned on aninner side of the deformation portion and comprises at least one pawlinsertable into the opening portion and engageable with the deformationportion.
 10. The tissue closure according to claim 1, wherein the sealportion is plate-shaped.
 11. The tissue closure according to claim 1,wherein the fastener portion, the seal portion and the deformationportion are integrally molded in one piece from the same material. 12.The tissue closure according to claim 1, wherein the fastener portionand the deformation portion are individually inclined with respect tothe seal portion.
 13. The tissue closure according to claim 1, whereinthe tissue closure is made of a bioabsorbable material.
 14. The tissueclosure according to claim 1, wherein the tissue closure is providedwith a hole through which a guide wire is to pass.
 15. The tissueclosure according to claim 1, wherein the fastener portion is providedwith a hole through which is to be threaded a string for pulling thetissue closure.
 16. The tissue closure according to claim 1, wherein theseal portion is made of polydioxanone.
 17. The tissue closure accordingto claim 1, wherein the seal portion possesses a length and a width, thelength of the seal portion being greater than the width of the sealportion.
 18. The tissue closure according to claim 1, wherein the sealportion possesses a length and a width, the length of the seal portionbeing equal to or greater than 4.0 mm, and equal to or less than 6.0 mm.19. The tissue closure according to claim 1, wherein the seal portionpossesses a front end portion and a rear end portion, a length of thefront end portion of the seal portion is equal to or greater than 3 mm.20. A tissue closing device, comprising: the tissue closure according toclaim 1, and an elongated arrangement device for removably retaining, ata distal end portion thereof, the tissue closure, the tissue closurebeing configured to be arranged in a living organism and close theopening penetrating the tissue membrane.
 21. The tissue closing deviceaccording to claim 20, further comprising displacement means fordisplacing the seal portion so that the seal portion extendssubstantially parallel to an axial direction of the arrangement device.22. The tissue closing device according to claim 21, wherein thedisplacement means comprises a contacting portion provided at a distalend portion of the arrangement device to contact a face of the sealportion on the sustaining portion side of the seal portion.
 23. Thetissue closing device according to claim 22, wherein the tissue closingdevice comprises a retainer for retaining the deformation portion of thetissue closure at the distal end portion of the arrangement device. 24.The tissue closing device according to claim 20, wherein the retainercomprises a deformation portion pulling means for pulling thedeformation portion to a proximal end side of the arrangement device.25. The tissue closure according to claim 20, wherein the arrangementdevice comprises a covered tube removably retaining the deformationportion, the covered tube possesses a retaining force that the coveredtube applies to retain the deformation portion, the retaining force isless than 1.2 kgf.
 26. A tissue closure for closing an opening whichpenetrates a tissue membrane of a living organism lumen, comprising: aseal portion configured to be inserted into the living organism lumen tocover the opening and a surrounding portion of the opening from an innersurface of the tissue membrane; the seal portion being formed such thatlongest portion of the seal portion possesses a length smaller than aninner diameter of the living organism lumen into which the seal portionis adapted to be inserted; a deformation portion; and a connectingportion connecting the seal portion to the deformation portion, theconnecting portion consisting of a single bendable plate so that theconnecting portion permits pivoting motion of the seal portion in onlyone plane.
 27. The tissue closure according to claim 26, wherein thedeformation portion is deformable between a first form in which thedeformation portion is configured to pass through the opening and asecond form in which the deformation portion is configured to cooperatewith the seal portion to sandwich the tissue membrane between the sealportion and the deformation portion from a side of the tissue membraneopposite the one side.
 28. The tissue closure according to claim 27,further comprising a fastener portion for retaining the deformationportion in the second form.
 29. The tissue closure according to claim26, wherein the seal portion is plated shaped with a length of a longestportion of the seal portion being equal to or less than 6 mm.
 30. Atissue closure for closing an opening penetrating a tissue membrane,comprising: a seal portion for covering the opening and a surroundingportion of the opening from one side of the tissue membrane; asustaining portion positionable on a side of the tissue membraneopposite the one side and cooperable with the seal portion to sandwichthe tissue membrane between the seal portion and the sustaining portionand sustain the seal portion on the one side of the tissue membrane; anda connecting portion connecting the sustaining portion to the sealportion, the connecting portion consisting of a single bendable plate sothat the connecting portion permits pivoting motion of the seal portionin only one plane.
 31. The tissue closure according to claim 30, whereinthe connecting portion is flexible such that upon bending the connectingportion the seal portion is turned.
 32. The tissue closure according toclaim 30, wherein the seal portion is plate shaped and the sustainingportion is framework shaped, the sustaining portion being deformablebetween a first form in which the sustaining portion is configured topass through the opening in the tissue membrane and a second form inwhich the sustaining portion is configured to cooperate with the sealportion to sandwich the tissue membrane between the seal portion and thesustaining portion with the sustaining portion on a side of the tissuemembrane opposite the one side.
 33. A tissue closing device for closingan opening which penetrates a tissue membrane, comprising: an elongatedbody element having a distal end portion configured to pass though theopening penetrating the tissue membrane; a tissue closure removablymounted at a distal end portion of the body element and configured topass through the opening together with the distal end portion of thebody element to close the opening; a deformation means for deforming aportion of the tissue closure; the tissue closure comprising: a sealportion configured to cover the opening and a surrounding portion of theopening from one side of the tissue membrane and configured to bepositioned at the one side of the tissue membrane; a deformation portionhaving a framework shape and deformable to a first form in which thedeformation portion is configured to pass through the opening anddeformable by the deformation means to a second form in which thedeformation portion is positioned on a side of the tissue membraneopposite the one side and cooperates with the seal portion to sandwichthe tissue membrane between the seal portion and the deformationportion; a connecting portion connecting the seal portion and thedeformation portion, the connecting portion consisting of a singlebendable plate so that the connecting portion permits pivoting motion ofthe seal portion in only one plane; and a fastener portion configured toretain the deformation portion in the second form after the seal portionis positioned at the one side of the tissue membrane.